Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)— 510(k) K190114

Substantially Equivalent

Convatec Limited

FDA 510(k) clearance K190114 for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector), Substantially Equivalent on 2019-04-30. Applicant: Convatec Limited.

Clearance details

Applicant: Convatec Limited
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2019-01-24
Decision date: 2019-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deeside, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.